MAUDE Adverse Event Report: ARTHREX, INC. GALILEO® LAG SCREW INSERTER; INTRAMED FIXATN ROD AND ACCESS

Model Number	GALILEO® LAG SCREW INSERTER
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 12/12/2024, it was reported by a sales representative via sems-06733992 that a 5033-100 galileo® capturing rod and an 5046-100 galileo® capturing rod nut will not unscrew and are stuck in the 5030-000 galileo® lag screw inserter.A backup set was available, and the case was completed without adverse effects on the patient.This was discovered during a procedure, with no reported patient harm.Additional information was requested.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.One unpackaged 5030-000 serial/batch number (b)(6) was received for evaluation.Functional testing was not performed because the device arrived for investigation with the 5033-100 and 5046-100 stuck inside.However, attempts to unscrew the knot were unsuccessful.A visual inspection revealed that the device shows numerous scratches and marks along the shaft.Regular signs of wear were noted on the handle.The most likely cause of the reported failure is misuse by the end user, who most likely cross-threaded the devices.

• Brand Name: GALILEO® LAG SCREW INSERTER
• Common Device Name: INTRAMED FIXATN ROD AND ACCESS
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 21113701
• Report Number: 1220246-2025-09319
• Device Sequence Number: 7539004
• Product Code: HSB
• UDI-Device Identifier: 00848665036244
• UDI-Public: (01)00848665036244(11)220406(10)220095
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K202099
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: GALILEO® LAG SCREW INSERTER
• Device Catalogue Number: 5030-000
• Device Lot Number: 220095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2024
• Supplement Date Received by Manufacturer: 01/28/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 02/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown